MedCity News

JUNE 14, 2023

2seventy Bio reported that an acute myeloid leukemia patient treated with its experimental cell therapy has died, prompting research partner Seattle Children’s Research Institute to pause the Phase 1 study. The FDA has been notified and an investigation is underway.

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MedCity News

FEBRUARY 12, 2024

FDA approval of Takeda Pharmaceutical drug Eohilia introduces a new therapeutic option for patients with eosinophilic esophagitis, inflammation of the esophagus that causes swallowing difficulty. It will compete against Dupixent, a Sanofi and Regeneron Pharmaceuticals drug already approved for this disorder.

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FDA Leads Pharmaceutical Patients 119

Pharmaceutical Technology

MAY 15, 2023

The company’s products Cometriq and Cabometyx are quinoline derivatives developed for the treatment of patients with advanced renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC). Zhejiang DTRM Biopharma and Oncore Biopharma stand in second and third positions, respectively.

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Leads Biopharma Pharmaceutical Pharma 92

European Pharmaceutical Review

AUGUST 24, 2023

This strategy shift did not occur overnight, but evolved in response to the changing biopharma landscape. Even among the leaders of the biopharma sector, few companies have a significant presence across these platforms, Baral highlighted. The post Divest to invest: the new normal in biopharma?

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European Pharmaceutical Review

MAY 12, 2023

Swedish Orphan Biovitrum AB (Sobi ® ) has agreed to acquire CTI BioPharma for $1.7 There is a large unmet medical need within myelofibrosis, in particular for patients suffering from thrombocytopenia who are inadequately treated by existing medicines.

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MedCity News

MARCH 7, 2023

BioMarin Pharmaceutical’s submission of additional data for patients treated with its hemophilia A gene therapy, Roctavian, mean that the FDA will push out a regulatory decision to early summer. But it could be worth the wait as analysts anticipate FDA approval and project Roctavian becoming one of BioMarin’s biggest products.

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FDA Leads Pharmaceutical Patients 110

MedCity News

APRIL 24, 2023

A clinical trial for a Foghorn Therapeutics cancer drug is under a partial FDA hold after a patient in the early-stage study developed a cardiovascular complication. It’s the biotech’s second partial hold in the past year.

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FDA Leads Patients Biopharma 108

Pharmaceutical Technology

MAY 10, 2023

Swedish Orphan Biovitrum (Sobi) has entered into a definitive agreement to buy biopharmaceutical company CTI BioPharma in an all-cash deal valued at $1.7bn. Vonjo has received the US Food and Drug Administration’s approval to treat myelofibrosis in adult patients with a platelet count below 50 x109/L.

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Biopharma Food and Drug Administration Food Medicine 59

MedCity News

MAY 29, 2023

Ray Therapeutics’ gene therapy is independent of the causative genes driving inherited vision disorders, which CEO Paul Bresge says is important for reaching a broad patient population. Rare disease retinitis pigmentosa is the first disease target, but the startup also plans to test its approach in more prevalent eye disorders.

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Leads Patients Biopharma Pharma 111

PM360

SEPTEMBER 15, 2022

The term “patient centricity” has been around for over a decade, and since its first utterance the buzzword has been praised, dissected, criticized, and everything in between. The concept has always been worthwhile, but people within and outside of the industry have wondered whether the industry was truly becoming more patient centric?

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Patients Healthcare Healthcare Marketing 98

MedCity News

JANUARY 3, 2023

By allowing study teams to design and conduct more inclusive and/or relevant studies, real-world data can enhance the standard of care and ultimately improve patient outcomes.

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Recruitment Leads Patients Biopharma 96

PM360

AUGUST 9, 2022

Biopharma blockbusters in the last 10 years show a disturbing trend. As a top 10 biopharma company leader shared with us, “Real blockbusters are gone. For biopharma, success in this space will require integrated models that are significantly different than what has been used with historic medicines. In oncology, it’s 47% less.

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Biopharma Marketing Healthcare Healthcare 69

MedCity News

JUNE 30, 2022

The FDA placed a partial clinical hold on late-stage tests of Sanofi multiple sclerosis drug tolebrutinib after some patients developed drug-induced liver injury. tests are paused, Sanofi said clinical testing in other countries is continuing with additional safety monitoring.

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FDA Leads Safety Patients 105

Pharmaceutical Technology

JUNE 2, 2023

Rentschler Biopharma has collaborated with Ikarovec for expediting the new gene therapies to treat ophthalmic disease. Under the deal, Rentschler Biopharma’s ATMP facility in Stevenage, UK, will undertake the bioprocess development of adeno-associated virus (AAV) material.

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Biopharma Manufacturing Leads Pharmaceutical 52

pharmaphorum

AUGUST 5, 2022

Over the past 15 years, more than 60% of asset growth among the top 30 biopharma companies came from acquisitions. Such inorganic growth is no longer viable, argues Pervaise Khan, Accenture’s UK Life Sciences Lead. And of course, all of this will feed into future treatments and positive patient outcomes – the sole purpose of pharma.

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Biopharma Marketing Pharma Relationship management 52

MedCity News

DECEMBER 9, 2024

Results from the Phase 3 DREAMM-7 study show GSK drug Blenrep is helping multiple myeloma patients live longer compared to treatment with blockbuster Johnson & Johnson drug Darzalex. The post GSK Multiple Myeloma Drugs DREAMM Comeback Continues With Phase 3 Data at ASH appeared first on MedCity News.

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FDA Leads Marketing Patients 116

European Pharmaceutical Review

APRIL 2, 2024

On his appointment , Wienand, incoming CEO, Lonza shared: “I am very much looking forward to joining Lonza and leading the company into a strong future… [helping to] serve as a partner of choice for the global biopharma industry in its quest to turn breakthrough innovations into viable therapies. billion.

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Biopharma Leads Manufacturing Pharmaceutical 98

MedCity News

APRIL 21, 2023

The new DEA ruling is doing a disservice not only to people with OUD, but to the entire medical care system—exacerbating a condition that will most likely lead to death.

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Physicians Patients Leads Medical 114

Pharmaceutical Technology

JANUARY 20, 2023

The demand for mAbs is increasing as they offer patients targeted treatments for a wide range of serious health conditions and diseases. Nevertheless, the potential for mAb therapies in treating medical conditions that have limited options means that biopharma companies are investing considerable resources in development.

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Pharmaceutical Technology

MAY 9, 2023

The companies will use the natural product discovery capabilities of Ginkgo Bioworks to expedite the discovery and development of new therapeutic molecules to address diseases with high unmet patient needs.

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Biopharma Sales Leads Patients 104

European Pharmaceutical Review

SEPTEMBER 27, 2023

Results from Small Pharma’s Phase Ib study in selective serotonin reuptake inhibitor (SSRIs) interaction with SPL026, native N, N-dimethyltryptamine (DMT) has revealed that 92 percent of patients gained remission from major depressive disorder ( MDD ). Currently, SSRIs are the standard of care for MDD.

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Pharma Biopharma Patients Leads 105

pharmaphorum

DECEMBER 16, 2022

The Japanese pharma says it will now start talking to regulatory authorities around the world about potential marketing applications for zolbetuximab as a first-line treatment for patients with locally advanced unresectable or metastatic gastric and gastro-oesophageal (GEJ) cancer. Claudin 18.2 Other companies developing claudin 18.2-targeted

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Leads Biopharma Prospecting Patients 59

pharmaphorum

JANUARY 6, 2023

From enabling patient choice during clinical trials to strengthening vital partnerships across the quality ecosystem, connected data will become the lifeblood that enables life sciences teams to collaborate efficiently and effectively in 2023. Patient choice will push sponsors toward operational excellence.

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Safety Management Patients Training 111

pharmaphorum

SEPTEMBER 6, 2022

Pleco Therapeutics has closed a first-round financing, raising just over €17 million that it says will fund the development of its lead therapy for acute myeloid leukaemia (AML) through to regulatory filings in the US and EU. million in equity and R&D funding from Belgian biopharma company Hyloris, which was first announced last year.

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Leads Biopharma Government Patients 103

pharmaphorum

DECEMBER 23, 2022

In 2022, life sciences companies have been hard at work breaking down silos to better serve patients and healthcare professionals (HCPs). With these silos breaking down, biopharmas will have the opportunity to drive a more coordinated approach to HCP engagement using shared data and unified systems, while still maintaining compliance.

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Marketing Sales Medical Patients 105

European Pharmaceutical Review

NOVEMBER 16, 2022

Engineering or redesigning facilities without due consideration of what is needed, of what may be superfluous, or of how systems and processes will be validated over time, could lead to costly remedial action and delays in getting important and premium new products to market. Embracing the spirit rather than the letter of regulations.

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Manufacturing Pharma Biopharma Management 119

Pharmaceutical Technology

APRIL 20, 2023

CBC CEO Fu Wei stated: “Hasten is a well-established Chinese biopharma company with tremendous growth potential. Hasten will also use the proceeds from the round to fund future acquisitions. The firm reported 47% growth in sales from Q2 to Q4 in 2022, which is testament to CBC’s unique and effective investor-operator strategy.

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Biopharma Healthcare Healthcare Sales 98

Pharmaceutical Technology

SEPTEMBER 8, 2022

Speciality pharmacies play a crucial role in medication dosing, disease and side effects management, and patient care. The expert services rendered by them help in improving patient outcomes, minimising costs of the healthcare system, improving medicinal adherence and persistency and saving clinicians’ time.

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Specialization Leads Pharma Side effects 45

Pharmaceutical Technology

JUNE 29, 2022

Continuing advancements within this field deliver new hope to doctors and patients, transforming disease outcomes for previously incurable indications. The quality grade is even more important in many novel therapeutic modalities because the specialty enzymes often form an integral part of the product and are closer to the patient.

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Specialization Biopharma B2B Sales Manufacturing 118

European Pharmaceutical Review

AUGUST 23, 2023

Retevmo’s potential in oncology The Phase III study LIBRETTO-531 enrolled 291 patients and is the first randomised trial to compare the safety and efficacy of a highly selective RET -kinase inhibitor with multikinase inhibitors in this patient population. More than 800 patients from 16 countries were included in the trial.

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Biopharma Safety Medical Patients 98

pharmaphorum

SEPTEMBER 21, 2022

The European Commission has followed the lead of the US FDA and approved AstraZeneca’s Tezspire as an add-on maintenance therapy for patients with severe asthma, becoming the first and only biologic that can be used in all patients, and not restricted to those with specific forms of the disease. billion or more.

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Sales Patients Medicine Biopharma 111

MedCity News

AUGUST 6, 2024

Its lead program is on track for Phase 2 testing in immunocompromised Covid-19 patients; a preclinical pan-influenza program is in development under a BARDA contract. Apple Tree Partners’ latest startup is Red Queen Therapeutics, developer of stapled peptide drugs that block viral fusion.

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Leads Patients Biopharma Pharma 116

European Pharmaceutical Review

MAY 2, 2024

As a result, the market is expected to reach $719 billion by 2030, 1 Sigma Mostafa, PhD, Chief Scientific Officer at KBI Biopharma shared with EPR. What excites me most is the continuous infusion of new modalities, unique conjugates, and enabling technologies leading to more targeted and effective therapies.

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Medicine Manufacturing Biopharma Engineering 105

pharmaphorum

JULY 4, 2022

Two weeks after reporting disappointing results for its lead coeliac disease therapy, 9 Meters Biopharma will draw some comfort from a mid-stage trial of its candidate for short bowel syndrome (SBS), although its share price remains under pressure. Some children are born with an abnormally short small intestine.

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Leads Biopharma Food Safety 98

pharmaphorum

JANUARY 9, 2023

Biopharma and healthcare group Chiesi Farmaceutici S.p.A. Supported by voting agreements from leading Amryt shareholders and directors, and unanimously approved and recommended by the boards of both companies, the total transaction is worth up to $1.48 is to acquire the 2015-established Amryt Pharma Plc. on 6 th January.

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Pharma Biopharma Management Medicine 98

PM360

DECEMBER 20, 2024

Courier Health Powered by machine learning AI, Avalere Courier Health was founded in 2021 with the goal of revolutionizing the biopharma landscape with its groundbreaking patient-focused customer relationship management (CRM) platform. It simplifies complex workflows (e.g., In July 2024, Courier Health secured $16.5

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Customer Relationship Management CRM Biopharma Relationship management 52

pharmaphorum

JULY 1, 2022

billion buyout of Principia Biopharma has run into trouble, after the FDA placed it on partial clinical hold while a safety signal is investigated. All the BTK inhibitors are designed to be able to cross the blood brain barrier and enter the central nervous system, dampening down the autoimmune response that leads to neuronal damage in MS.

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Side effects Safety Biopharma Recruitment 98